What’s New in the Patient Safety World

January 2015



·         Beneficial Effect of EMR on Patient Safety

·         More Data on Effect of Resident Workhour Restrictions

·         Emergency Surgery Also Very Costly

·         ECRI Institute’s Top 10 Technology Hazards for 2015




Beneficial Effect of EMR on Patient Safety



Other than studies coming from a few pioneering academic medical centers with home grown EMR’s, convincing evidence for a beneficial effect of EMR’s on patient safety has been scant. But a new study using data from the Pennsylvania Patient Safety Authority (PPSA) and the HIMSS Analytics database demonstrates a substantial decrease in patient safety events at hospitals with advanced EMR’s (Hydari 2014). Advanced EMR’s were those in which CPOE and physician documentation had been implemented (as opposed to basic EMR’s which have a clinical data repository and clinical decision support). The researchers found that advanced EMRs led to a 27 percent decline in patient safety events overall, driven by a 30 percent decline in events due to medication errors and 25 percent decline in events due to complications of tests, treatments and procedures. The results remained robust after adjustment for multiple factors such as hospital case mix, patient demographics, teaching status, hospital size, etc.


A strength of the study is that all Pennsylvania hospitals report patient safety events to the PPSA database. On the other hand, data in the HIMSS database is self-reported by hospitals and may not be completely accurate. You’ll also need an advanced degree in biostatistics to understand all the nuances of their “robustness” checks!


But the data are very encouraging and seem to confirm our longstanding faith that EMR’s would eventually deliver, at least on the patient safety side of the equation (the fiscal side may be a different story).


When used well, the data from electronic medical records can be extremely helpful for quality and patient safety. Alerts and reminders generated on algorithms using clinical and laboratory elements in the EMR need to be validated, evidence-based, have good sensitivity and specificity, and be actionable or provide alternative options, and be delivered to the person most likely to perform the appropriate intervention (the latter not always being the physician).


In our November 11, 2014 Patient Safety Tip of the Week “Early Detection of Clinical Deterioration” we noted how use of data from electronic sources can was able to detect clinical deterioration early and reduce mortality rates. Another new study demonstrated that an early warning and response system for sepsis resulted in a significant increase in early sepsis care, ICU transfer, and sepsis documentation (Umscheid 2014). There was also a trend toward decreased sepsis mortality and increased discharge to home that did not reach statistical significance. The system was based on laboratory values and vital signs from the electronic health record monitored in real time. If a patient had ≥4 predefined abnormalities at any single time, the provider, nurse, and rapid response coordinator were notified and performed an immediate bedside patient evaluation. And we’ve done several columns on use of decision support tools to avoid Torsade de Pointes (see our June 10, 2014 Patient Safety Tip of the Week “Another Clinical Decision Support Tool to Avoid Torsade de Pointes”.


But not everyone is using EMR’s to their fullest extent and there continue to be unexpected consequences of EMR’s.


In fact, ECRI Institute has recently released its annual report on the Top 10 Health Technology Hazards and “Data Integrity: Incorrect or Missing Data in EHRs and Other Health IT Systems” is #2 on the list for 2015. Among the examples the report identifies in this category are:


Way back when we first began participating in EMR implementations we recognized the risks of entering information or orders into the wrong patient’s record (see our May 20, 2008 “CPOE Unintended Consequences – Are Wrong Patient Errors More Common?”). We continue to see systems in which a physician can have more than one patient’s medical record online simultaneously (for example, one might have one patient’s imaging report showing in a radiology PACS system and another patient’s record showing on a CPOE screen). It’s easy to see how such “wrong patient” errors can occur in those circumstances. In fact, this problem is so prevalent that AHRQ has just awarded a substantial grant to study the problem (Montefiore News Release 2014).


Even well-intentioned EMR-related projects may result in unintended consequences. A recent case report showed how trying to fit a standardized order set into an inflexible EMR resulted in serious consequences to patients (Manley 2014). Recognizing that continuous bladder irrigation (sometimes used for patients with gross hematuria and a few other conditions) was being managed more and more by staff not very familiar with its use, standardized order sets were developed. Such irrigation is typically done via low gravity so that pressure inside the bladder does not rise to dangerous levels. Because the EMR would not accept infusions without specifying rates, those developing the order set felt the orders would be similar to IV orders and require rates in the order. Staff began bladder infusions using infusion pumps, resulting in bladder rupture in at least one patient. The report goes on to describe how a multidisciplinary team analyzed cases and worked collaboratively to develop a good standardized order set.


And, of course, we continue to see that many EMR’s have notes of various providers in silos such that they are seldom read by others (see our October 2014 What’s New in the Patient Safety World column “Ebola Exposes Fundamental Flaw”).


These are but a few examples of the downside of the EMR. Below are listed some of our prior columns on the unintended consequences of EMR’s. But the recent study using the PPSA database (Hydari 2014) is encouraging and suggests that we are finally turning the corner on fulfilling the promise of EMR’s to improve patient safety.




See some of our other Patient Safety Tip of the Week columns dealing with unintended consequences of technology and other healthcare IT issues:









Hydari MZ, Telang R, Marella WM. Saving Patient Ryan - Can Advanced Electronic Medical Records Make Patient Care Safer? (September 30, 2014). Available at SSRN:




Umscheid CA, Betesh J, VanZandbergen C, et al. Development, implementation, and impact of an automated early warning and response system for sepsis. J Hosp Med 2014; Article first published online: 26 SEP 2014




ECRI Institute. ECRI Institute 2015 Top 10 Health Technology Hazards. A Report from Health Devices. November 2014




Montefiore News Release. AHRQ Grant Awarded to Study the Impact of Health IT on Patient Safety at Montefiore and Einstein and Brigham and Women’s Hospital. September 24, 2014




Manley BJ, Gericke RK, Brockman JA, et al. The pitfalls of electronic health orders: development of an enhanced institutional protocol after a preventable patient death. Patient Safety in Surgery 2014, 8: 39






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More Data on Effect of Resident Workhour Restrictions



In the late 1980’s New York State adopted recommendations of the Bell Commission to limit the number of hours housestaff could work in a week. Subsequently other states and the ACGME have adopted significant restrictions in housestaff hours. The ACGME 80-hour work week restriction was implemented in 2003 and the ACGME in 2011 mandated 16-hour duty maximums for PGY-1 residents.


These recommendations have been based on the well-known impact of fatigue on healthcare workers (see list of our prior columns below). But we suspected even back in the 1980’s that benefits from reduced housestaff fatigue might well be offset by detrimental effects of increased cross-coverage and an increased number of handoffs that would occur after the change in housestaff hours. Significantly, most of the restrictions on housestaff work hours were implemented without any formal or systematic measurement of its impact on patient outcomes or for recognition of unintended consequences.


The subsequent evidence of the impact of restricted housestaff hours on patient outcomes and patient safety has been mixed and contradictory (see list of our prior columns below). And any study looking at the impact of restricted work hours needs to look at patient outcomes, adverse events, housestaff wellness and well-being, and how well we educate and prepare our residents for their future practice in healthcare.


Add to those prior studies several new studies. Two such studies recently appeared in JAMA. In the first (Patel 2014) the authors found no significant differences among Medicare beneficiaries in the change in 30-day mortality rates or 30-day all-cause readmission rates for those hospitalized in more intensive relative to less intensive teaching hospitals in the year after implementation of the 2011 ACGME duty hour reforms compared with those hospitalized in the 2 years before implementation.


The second study (Rajaram 2014) found that implementation of the 2011 ACGME duty hour reform was not associated with a change in general surgery patient outcomes or differences in resident examination performance.


In addition, another systematic review (Harris 2014) found some support for improved resident quality of life and improved resident sleep and less fatigue but a perceived negative impact on surgical operative and technical skill and conflicting evidence on the topics of resident education, patient outcomes, and variable attitudes toward the work-hour changes. The authors again noted there is a paucity of high-level or clear evidence evaluating the effect of the changes to resident work hours.



Virtually all the studies to date have been observational studies, usually with a before-after format. Most of us have doubted that a true randomized controlled trial could ever be done regarding the impact of workhour restrictions. But, in fact, two such trials are planned, with support from the ACGME. The FIRST Trial will be a prospective trial to examine how increasing flexibility of surgical resident duty hour requirements affects patient care, surgical outcomes, and resident perceptions. Hospitals will be randomized to either an intervention group with flexibility of duty hour restrictions (elimination of many duty hour requirements) or a control group with continued adherence to current requirements. Those hospitals randomized to the intervention arm will be granted a waiver from current duty hour requirements by the ACGME.


The iCOMPARE trial is a one-year cluster randomized trial that will assign participating ACGME-accredited Internal Medicine training programs to one of two duty-hour regimens:

Outcomes include measures of patient safety and trainee education. The ACGME will provide duty hour waivers to all participating programs from July 2015 through at least June 2019 (or until action is taken on duty hour policy).


Let’s hope these two trials can help answer some of the questions outstanding regarding multiple aspects of the impact of resident work hour restrictions.




Some of our other columns on housestaff workhour restrictions:


December 2008           IOM Report on Resident Work Hours

February 26, 2008       Nightmares: The Hospital at Night

January 2010               Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 2011               No Improvement in Patient Safety: Why Not?

November 2011          Restricted Housestaff Work Hours and Patient Handoffs

January 3, 2012           Unintended Consequences of Restricted Housestaff Hours

June 2012                    Surgeon Fatigue

November 2012          The Mid-Day Nap

December 10, 2013     Better Handoffs, Better Results

April 22, 2014             Impact of Resident Workhour Restrictions



Some of our other columns on the role of fatigue in Patient Safety:


November 9, 2010      12-Hour Nursing Shifts and Patient Safety

April 26, 2011             Sleeping Air Traffic Controllers: What About Healthcare?

February 2011             Update on 12-hour Nursing Shifts

September 2011          Shiftwork and Patient Safety

November 2011          Restricted Housestaff Work Hours and Patient Handoffs

January 2010               Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 3, 2012           Unintended Consequences of Restricted Housestaff Hours

June 2012                    June 2012 Surgeon Fatigue

November 2012          The Mid-Day Nap

November 13, 2012    The 12-Hour Nursing Shift: More Downsides

July 29, 2014               The 12-Hour Nursing Shift: Debate Continues

October 2014              Another Rap on the 12-Hour Nursing Shift

December 2, 2014       ANA Position Statement on Nurse Fatigue







Patel MS, Volpp KG, Small DS, et al. Association of the 2011 ACGME Resident Duty Hour Reforms With Mortality and Readmissions Among Hospitalized Medicare Patients. JAMA 2014; 312(22): 2364-2373




Rajaram R, Chung JW, Jones AT, et al. Association of the 2011 ACGME Resident Duty Hour Reform With General Surgery Patient Outcomes and With Resident Examination Performance. JAMA 2014; 312(22): 2374-2384




Harris JD, Staheli G, LeClere L, et al. What Effects Have Resident Work-hour Changes Had on Education, Quality of Life, and Safety? A Systematic Review. Clinical Orthopaedics and Related Research 2014; October 2014 Published online: 01 Oct 2014




The FIRST Trial. Flexibility In duty hour Requirements for Surgical Trainees Trial.




iCOMPARE Trial (Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education)






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Emergency Surgery Also Very Costly



Surgery done on an emergency basis and surgery done “after-hours” is associated with more complications, more morbidity, and often more mortality (see our What’s New in the Patient Safety World columns for September 2009 After-Hours Surgery – Is There a Downside?”, October 2014 “What Time of Day Do You Want Your Surgery?”, and December 2014 “Another Procedure to Avoid Late in the Day or on Weekends”).


One consideration we’ve not discussed much is cost. Cases done after hours have variable costs higher than those done during normal hours (overtime, etc.) and the resultant increase in complications and morbidity have additional incremental costs as well. Since most cases are reimbursed with DRG or similar methodology hospitals seldom recoup the full incremental costs of doing such cases after hours.


Now a new study has assessed the financial impact of emergency vs. elective surgery (Haider 2014). Using Nationwide Inpatient Sample (NIS) data the authors investigated costs and mortality for three procedures: abdominal aortic aneurysm repair, coronary artery bypass graft, or colon resection for neoplasm. The adjusted mean cost differences for emergent versus elective care ranged from $5309.78 to $8741.22 for the three procedures. The authors estimate that if 10% of the weighted estimates of emergency procedures had been performed electively, the cost benefit would have been nearly $1 billion. Elective surgery patients had significantly lower adjusted odds of mortality for all procedures.


Of course, there are big differences between the types of cases described by Haider et al. and those we have previously described. Most of the ones we’ve discussed are not likely true emergencies (even though they are often categorized as such). Those described by Haider et al. probably were truly emergent (eg. rupture of an AAA, bowel obstruction from a colon cancer, etc.). Moreover, the three conditions chosen for analysis by Haider et al. are ones where access to primary care and screening may have led to earlier detection and interventions that need not be done on an emergent basis. The message in the Haider study, therefore, is important for health plans and accountable care organizations as well as hospitals.


Nevertheless, you get the picture: surgeries that can be done on an elective rather than emergency basis are less costly – from both a human and financial perspective. We again urge all hospitals to take a look at surgeries and procedures done “after hours” and determine how often such cases are truly “emergent”. When you identify those that were not truly “emergent” you need to do root cause analyses and identify what factors contributed to the decision to intervene after hours and which could be potentially modifiable by system changes.


Why should “after hours” surgery be more prone to adverse outcomes than regularly scheduled elective surgery? There are many reasons aside from the fact that patients needing emergency and after hours surgery are generally sicker. You are operating with a team that is likely different from your daytime team. All members of that team (physicians, nurses, anesthesiologists, techs, etc.) may not have the same level of expertise as your regular daytime team and the team dynamics between members is likely to be different. The post-surgery recovery unit is likely to be staffed much differently after-hours as well. The staff may be more likely to be unfamiliar with things like location of equipment. And some of the other hospital support services (eg. radiology, laboratory) may have lesser staffing after-hours. Just as importantly, many or all of the “on-call” staff that make up the after-hours surgical team have likely worked a full daytime shift that day so fatigue enters as a potential contributory factor. And there are always time pressures after hours as well. In addition, one of the most compelling reasons surgery is done at night rather than deferred to the next morning is the schedule of the surgeon or other physician for that next morning (either in surgery or the cath lab or his/her office). Because the surgeon does not want to disrupt that next day schedule, he/she often prefers to go ahead with the current case at night. Similarly, many hospitals run very tight OR schedules and adding a case from the previous night can disrupt the schedule of many other cases.


We highly recommend hospitals take a hard look at surgical cases done “after hours”. In particular, you need to determine which cases truly needed to be done after hours and, perhaps more importantly, which ones could have and should have been done during “regular hours”. If the latter are significant, you need to consider system changes such as reserving some “regular hours” for such cases to be done the following morning. You may have to alter the scheduling of cases for individual surgeons as well. For example, perhaps the surgeon on-call tonight should not have elective cases scheduled tomorrow morning. That way, if a case comes in tonight that should be done tomorrow morning you will have both a “free” OR room and a “free” surgeon. And you would need to develop a list of criteria to help you triage cases into “regular” or “after-hours” time slots.






Haider AH, Obirieze A, Velopulos CG, et al. Incremental Cost of Emergency Versus Elective Surgery. Annals of Surgery 2014; published online ahead of print December 17, 2014






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ECRI Institute’s Top 10 Technology Hazards for 2015



Each year ECRI Institute puts out its list of the top 10 health technology hazards. The ECRI Institute Top 10 Health Technology Hazards for 2015 list is now out:

  1. Alarm hazards: Inadequate alarm configuration policies and practices
  2. Data integrity: Incorrect or missing data in electronic health records and other health IT systems
  3. Mix-up of IV lines leading to misadministration of drugs and solutions
  4. Inadequate reprocessing of endoscopes and surgical instruments
  5. Ventilator disconnections not caught because of mis-set or missed alarms
  6. Patient-handling device use errors and device failures
  7. “Dose creep”: Unnoticed variations in diagnostic radiation exposures
  8. Robotic surgery: Complications due to insufficient training
  9. Cybersecurity: Insufficient protections for medical devices and systems
  10. Overwhelmed recall and safety alert management programs


As usual, ECRI Institute provides excellent recommendations at preventing or mitigating the impact of incidents related to each of these hazards.


Issues related to alarm management and information technology dominate the list. Leading the list again is alarm hazards and this should be no surprise. But alarm issues leading to ventilator disconnections got its own place on this year’s list. Robotic surgery and inadequate reprocessing of endoscopes and instruments are holdovers from last year. Issues related to patient-handling devices (lifts, transfer devices, etc.) may not sound particularly hi-tech but staff need education on the use and maintenance of all such devices. Similarly, the focus on IV’s this year is not so much on the hi-tech infusion devices but rather on making sense out of the tangle of IV lines linked to our sickest patients. Also new to this year’s list is hazards related to recall and safety alerts. We’re pleased to see that make the list. Our February 26, 2013 Patient Safety Tip of the Week “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?” highlighted the problem of hospitals having inadequate systems to deal with such alerts or recalls.



We won’t steal ECRI’s thunder. Read the report yourself. The full report can be downloaded free at the ECRI Institute website. This is a very informative and useful document that you should make full use of.






ECRI Institute. ECRI Institute Announces Top 10 Health Technology Hazards for 2015. Press Release November 25, 2014


report download site:





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